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Vitamin D + Omega-3 for Depression (VITAL-DEP Trial)

N/A
Waitlist Available
Led By Olivia I Okereke, MD, SM
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No history of major neurologic disorder or delirium episode in the past 12 months
No core major depressive disorder symptoms for a period of two or more weeks in the past two years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, follow-up year 1, follow-up year 2, follow-up year 3, follow-up year 4, and follow-up year 5

Summary

This trial is studying whether taking vitamin D3 or omega-3 fatty acids supplements reduces the risk of developing cancer, heart disease, and stroke. This study will also examine whether either of these supplements reduces the risk of clinical depression or improves mood scores over time.

Who is the study for?
This trial is for adults in the VITAL study without a history of major neurological disorders, clinical hypothyroidism, significant depression, or recent substance abuse. They shouldn't be on psychotherapy or psychotropics (except mild sedatives) and must not have had core depressive symptoms for two weeks in the past two years.
What is being tested?
The VITAL-DEP study tests if daily supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram fish oil) can prevent clinical depression and improve mood over time compared to placebos in individuals without prior cancer, heart disease, or stroke.
What are the potential side effects?
Potential side effects from omega-3s may include a fishy aftertaste, upset stomach, and nausea. Vitamin D might cause fatigue, weakness, dry mouth or a metallic taste. Placebos typically have no active ingredients but can still result in side effects due to the placebo effect.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't had a major neurological disorder or delirium in the last year.
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I haven't had major depression symptoms for 2+ weeks in the last 2 years.
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I have never been diagnosed with overt hypothyroidism.
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I am not currently experiencing significant depression.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, follow-up year 1, follow-up year 2, follow-up year 3, follow-up year 4, and follow-up year 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, follow-up year 1, follow-up year 2, follow-up year 3, follow-up year 4, and follow-up year 5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mood Scores
Number of Participants With a Depression Event
Other study objectives
Number of Participants With a Recurrent Depression Event
Number of Participants With an Incident Depression Event

Trial Design

4Treatment groups
Active Control
Group I: Vitamin D + fish oil placeboActive Control2 Interventions
Vitamin D3 (cholecalciferol), 2000 IU per day Fish oil placebo
Group II: Vitamin D placebo + fish oil placeboActive Control2 Interventions
Vitamin D placebo Fish oil placebo
Group III: Vitamin D + fish oilActive Control2 Interventions
Vitamin D3 (cholecalciferol), 2000 IU per day Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\])
Group IV: Vitamin D placebo + fish oilActive Control2 Interventions
Vitamin D placebo Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\])

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,658 Previous Clinical Trials
11,681,219 Total Patients Enrolled
28 Trials studying Depression
97,602 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,892 Previous Clinical Trials
2,704,374 Total Patients Enrolled
696 Trials studying Depression
242,443 Patients Enrolled for Depression
Olivia I Okereke, MD, SMPrincipal InvestigatorBrigham and Women's Hospital

Media Library

Fish Oil Placebo Clinical Trial Eligibility Overview. Trial Name: NCT01696435 — N/A
Depression Research Study Groups: Vitamin D + fish oil placebo, Vitamin D placebo + fish oil placebo, Vitamin D + fish oil, Vitamin D placebo + fish oil
Depression Clinical Trial 2023: Fish Oil Placebo Highlights & Side Effects. Trial Name: NCT01696435 — N/A
Fish Oil Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT01696435 — N/A
~1203 spots leftby Oct 2025
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